FDA.reportPublic FDA data

METHOTREXATE

Product NDC
55150-511
11-digit product format
551500511
Labeler code
55150
Product ID
55150-511_adc6f7e8-b3a3-476a-9939-0c5cbda63dbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHOTREXATE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Eugia US LLC
Application
ANDA201529
Marketing category
ANDA
Marketing start
2024-09-11
Substance
METHOTREXATE SODIUM
Active strength
100 mg/4mL
Pharmacologic classes
Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2012-03-29
A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2012-03-29
A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2012-03-29
A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2012-03-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A201529-001AP
A201529-002AP
A201529-003AP
A201529-004AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2012-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2012-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2012-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAP2012-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201529-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 50MG BASE/2ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201529-002METHOTREXATE SODIUM PRESERVATIVE FREEEQ 100MG BASE/4ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201529-003METHOTREXATE SODIUM PRESERVATIVE FREEEQ 200MG BASE/8ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201529-004METHOTREXATE SODIUM PRESERVATIVE FREEEQ 250MG BASE/10ML (EQ 25MG BASE/ML)INJECTABLE / INJECTION2012-03-29d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A201529-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A201529-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A201529-003AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A201529-004AP1caaa826d4ba7…
2019-12-13 00:20 UTC2019-12A201529-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201529-002AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201529-003AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201529-004AP174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201529-004AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A201529-004AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201529-004AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201529-004AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201529-001AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A201529-002AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A201529-003AP13f01610625f2…
2019-12-14 00:12 UTC2019-12A201529-004AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A201529-001AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201529-002AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201529-003AP1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201529-004AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201529-001AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201529-002AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201529-003AP1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201529-004AP1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201529-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201529-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201529-003AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A201529-004AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
METHOTREXATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE SODIUM100 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3IG1E710ZNInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1655959Internal RxNorm lookup
1655960Internal RxNorm lookup
1655967Internal RxNorm lookup
1655968Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63bb6fbf-dd59-4edc-af8f-d0c397ca1262Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0Product name920250224
3082de91-569a-4d57-b379-acbf37f1d5c3Product name120210312
f76135bc-a210-42d9-851b-1b73cbaccdb3Product name120200511
423544b2-e325-49ee-8910-4c5dfe41906fProduct name120181120
c9fd924b-0a8d-4d53-bf70-11070e24e4ddProduct name220181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359Product name120181120
eb454f54-2806-4c31-a08b-8dcb08261099Product name220181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27Product name120170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3Product name220160504
88514aea-9d58-4ed2-b135-9811fb14c8fbProduct name120141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-511-01METHOTREXATE01 in 1 CARTONINJECTION, SOLUTION012
55150-511-01METHOTREXATE4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION42
55150-511-10METHOTREXATE10 in 1 CARTONINJECTION, SOLUTION102
55150-511-10METHOTREXATE4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-511METHOTREXATE INJECTION, SOLUTION [EUGIA US LLC]1Current NDC, 4 package rows20250215_63bb6fbf-dd59-4edc-af8f-d0c397ca1262.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
METHOTREXATEMETHOTREXATEEugia US LLC63bb6fbf-dd59-4edc-af8f-d0c397ca12622025-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201529
application number: ANDA201529
ndc (product): 55150-511

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655967methotrexate 100 MG in 4 ML InjectionPSN63bb6fbf-dd59-4edc-af8f-d0c397ca12622
1655968methotrexate 200 MG in 8 ML InjectionPSN63bb6fbf-dd59-4edc-af8f-d0c397ca12622
1655959methotrexate 250 MG in 10 ML InjectionPSN63bb6fbf-dd59-4edc-af8f-d0c397ca12622
1655960methotrexate 50 MG in 2 ML InjectionPSN63bb6fbf-dd59-4edc-af8f-d0c397ca12622
165595910 ML methotrexate 25 MG/ML InjectionSCD63bb6fbf-dd59-4edc-af8f-d0c397ca12622
16559602 ML methotrexate 25 MG/ML InjectionSCD63bb6fbf-dd59-4edc-af8f-d0c397ca12622
16559674 ML methotrexate 25 MG/ML InjectionSCD63bb6fbf-dd59-4edc-af8f-d0c397ca12622
16559688 ML methotrexate 25 MG/ML InjectionSCD63bb6fbf-dd59-4edc-af8f-d0c397ca12622
1655967methotrexate 100 MG per 4 ML InjectionSY63bb6fbf-dd59-4edc-af8f-d0c397ca12622
1655968methotrexate 200 MG per 8 ML InjectionSY63bb6fbf-dd59-4edc-af8f-d0c397ca12622
1655959methotrexate 250 MG per 10 ML InjectionSY63bb6fbf-dd59-4edc-af8f-d0c397ca12622
1655960methotrexate 50 MG per 2 ML InjectionSY63bb6fbf-dd59-4edc-af8f-d0c397ca12622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
55150-511-01551500511011 VIAL, SINGLE-DOSE in 1 CARTON (55150-511-01) / 4 mL in 1 VIAL, SINGLE-DOSE2024-09-11NoNoCurrent
55150-511-105515005111010 VIAL, SINGLE-DOSE in 1 CARTON (55150-511-10) / 4 mL in 1 VIAL, SINGLE-DOSE2024-09-11NoNoCurrent